The definition of the term "premature ejaculation" according to DSM-III-R is "a presistent or recurrent ejaculation with-minimal sexual stimulation before, upon or shortly after penetration and before the person wishes it".
To a man skilled in the art the terms "erectile dysfunction" and "premature ejaculation" are two entirely separate concepts based on different etiologies (see British Journal of Hospital Medicine, Vol 40, Dec. 1988, p. 428 och 434).
Studies have shown that PME is a widespread problem in sexual relationships. Indeed, mention is made of as much as 75 % of men ejaculating within 2 minutes after penetration, and an important number of men reaching climax even within 1 minute of coitus.
This situation may be the cause of psychological disturbances for the man suffering from PME, as well as for his female partner.
There is no reliable documentation identifying the etiology of PME, but different theoretical concepts exist. They relate the problem 1) hypersensitivity of the glans penis, resulting in excessive stimulation of the sexual center in the central nervous system, 2) anxiety, 3) destructive interactional patterns, 4) learning and conditioning from early sexual experiences, and 5) multi-factorial causes.
The presently existing methods of treating PME are on the one hand of a psychological or "technical" type, such as the "pause-squeeze" method (W. H. Masters and V. E. Johnson, Human Sexual Inadequacy, Little; Brown & Company, Boston, Mass., 1970) and on the other hand of the pharmacological type. Thus, a variety of pharmacological techniques have been reported to delay or block an ejaculatory response. While reporting variable success rates, studies have been largely uncontrolled. Apart from the use of systemic drugs such as antidepressants or beta blockers, with evident drawbacks resulting from the side effects of the pharmaceutical, one of the interventions has been to apply topical anaesthetic to the penis before the sexual intercourse (Schapiro, J. Urology, 50, 374-379, 1943. Aycock, J. Urology, 62, 361-362, 1949. Damrav, J. Urology, 89, 936-939, 1963).
However, the use of the local anaesthetic alone has in most instances given only mediocre improvments, prolonging the coitus with on the average less than 2 minutes.
U.S. Pat. No. 3 363 624 to Fishman discloses a medicated prophylactic device comprising, in combination, an elastic tubular sheet having an open proximal end and a closed distal end, and provided adjacent the inner surface of the distal end thereof with about 0,2 to 5 cc. of a readily water-dispersible desensitizing composition, containing about 0,5 to25 % by weight of a desentizing agent, the amount of said composition and the concentration of the desensitizing agent in said composition being effective for only temporarily desensitizing a body member inserted in said device. The protective sheath, when used on the male organ increases the period of active intercourse prior to spermatic emission. However, at column 3, lines 19-23 it is stated that "For use on the male organ, an amount of desensitizing composition only sufficient to coat the glans penis or head of the male organ need be applied to the inner surface of the sheath.
U.S. Pat. No. 4 840 188 to Heidenfelder discloses a condom for use by a male human during sexual intercourse comprising a phallic-shaped elastic sheath having a closed end and an open end, a local coating on the inside surface of said closed end, said local coating consisting essentially of a topical anesthetic for delaying ejaculation by said male human during sexual intercourse and a water-soluble base therfor, and a small colored bump on said sheath solely adjacent to said open end, said mark being visually distinct from the color of said sheath and visually indicating said inside surface on which said local coating is located. At column 1, lines 11-13 it is stated that: By "local coating" is meant a coating over only a limited area of the inner surface.
Thus, it is obvious that prior art dissuades from the use of anaesthetics on the whole or substantially the whole inside surface of the condom.
EP 0 266 968 relates to a diagnostic and therapeutic method for human erectile failure by administering a smooth muscle relaxant to the human penile arteries. The aim with the use of a condom is according to p. 4 lines 10-18 to control abuse of the drug.
WO 89/11853 discloses the use of local anaesthetic agents in the manufacture of preparations with wound healing effects especially for the treatment of leg ulcers.
Thus, the dressing or use as disclosed by the present application are not anticipated by known prior art.
It is generally admitted that the mechanism of action of topical anaesthetics consists of a blocking of the pain skin receptors and pain fibers, thus providing analgesia. The local anaesthetics may also block the tactile receptors and the nerve fibers that convey the tactile sensory input, which is important for ejaculation.
Many topical anaesthetics in use for local analgesia have existed on the market for a long period or time, e.g. the last 30 years. They have been used among others in procedures involving the male and female urethra and as anaesthetic lubricant for endotracheal intubation (oral or nasal). They accordingly have had time to be well studied and have rare skin and mucosal irritation (less than 1/1000).